PRENATAL 19- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin,

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), P

Available from:

Nationwide Laboratories, LLC

INN (International Name):

.BETA.-CAROTENE

Composition:

.BETA.-CAROTENE 1000 [iU]

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PreNatal 19 tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. PreNatal 19 tablets are also useful in improving the nutritional status of women prior to conception. This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Product summary:

PreNatal 19 tablets for oral administration are supplied as white, coated, oblong tablets debossed "C41," packaged in bottles of 100 tablets. NDC 42937-706-10. Store at room temperature, USP. Protect from moisture and excessive heat. Avoid freezing.

Authorization status:

unapproved drug other

Summary of Product characteristics

PRENATAL 19- .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL,
.ALPHA.-TOCOPHEROL ACETATE, DL-,
THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE
HYDROCHLORIDE, FOLIC ACID,
CYANOCOBALAMIN, CALCIUM PANTOTHENATE, CALCIUM CARBONATE, FERROUS
FUMARATE, ZINC OXIDE, AND
DOCUSATE SODIUM TABLET, COATED
NATIONWIDE LABORATORIES, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
PRENATAL 19
DESCRIPTION
PreNatal 19 provides oil soluble vitamins, water-soluble vitamins and
minerals.
EACH TABLET CONTAINS:
VITAMIN A (as beta carotene)
1000 IU
VITAMIN C (ascorbic acid)
100 mg
VITAMIN D (as cholecalciferol)
400 IU
VITAMIN E (as dl-alpha-tocopheryl
acetate)
30 IU
THIAMINE MONONITRATE (Vitamin B )
3 mg
RIBOFLAVIN (Vitamin B )
3 mg
NIACIN (as niacinamide)
15 mg
VITAMIN B (as pyridoxine HCl)
20 mg
FOLATE (folic acid)
1 mg
VITAMIN B
(as cyanocobalamin)
12 mcg
PANTOTHENIC ACID
(as calcium pantothenate)
7 mg
CALCIUM (as calcium carbonate)
200 mg
IRON (as ferrous fumarate)
29 mg
ZINC (as zinc oxide)
20 mg
DOCUSATE SODIUM
25 mg
OTHER INGREDIENTS
Carnauba Wax, Fumed Silica, Gum Arabic, Hydroxy Propyl Methyl
Cellulose, Magnesium Stearate,
Microcrystalline Cellulose, Polyethylene Glycol, Stearic Acid, Talc,
and Titanium Dioxide.
INDICATIONS
PreNatal 19 tablets are indicated for use in improving the nutritional
status of women throughout
pregnancy and in the postnatal period for both lactating and
non-lactating mothers. PreNatal 19 tablets
are also useful in improving the nutritional status of women prior to
conception.
CONTRAINDICATIONS
This product is contraindicated in patients with a known
hypersensitivity to any of the ingredients.
WARNINGS
1
2
6
12
Folic acid alone is improper therapy in the treatment of pernicious
anemia and other megaloblastic
anemias where vitamin B
is deficient.
WARNING
ACCIDENTAL OVERDOSE OF IRON-CONTAINING PRODUCTS IS A LEADING CAUSE OF
FATAL POISONING IN
CHIL